Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)
Status unconfirmed · Has a placebo group
Conditions studied: Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment
In brief
A naturalistic study design, in which dTMS patients will be randomized to get a free add-on CBT treatment. The dTMS procedure will include treatment as usual, and participants will use the app from post randomization (Pre-treatment is defined as measures from the first three days of treatment) to the end of dTMS treatment (Post-treatment which is defined as measures from after twenty TMS sessions over a minimum of four weeks), and for an additional three months of FU (FU).
Key facts
- Study ID
- NCT04455646
- Run by
- Brainsway
- People needed
- 540
- Starts
- 2019-08-26
- Expected to finish
- 2021-08-26
- Last updated by the study team
- 2020-07-09
Who can join
Age: 22 and older, up to 68. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult outpatients accepted to treatment as usual dTMS with a Primary DSM-V diagnosis of Major Depression, single or recurrent episode
- Capable and willing to provide informed consent
- In a possession of a Smartphone capable of running the GGDE app.
- Able to adhere to the treatment schedule.
You may not qualify if…
- Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
Where it is running
- Kadima Neuropsychiatry — San Diego, California, United States (enrolling)
- Advanced Mental Health Care Inc. - Juno Beach — Juno Beach, Florida, United States (enrolling)
- Advanced Mental Health Care Inc. - Palm Beach — Palm Beach, Florida, United States (enrolling)
- Advanced Mental Health Care Inc. - Royal Palm Beach — Royal Palm Beach, Florida, United States (enrolling)
- Greenbrook - Annapolis — Annapolis, Maryland, United States (enrolling)
- Greenbrook - Columbia — Columbia, Maryland, United States (enrolling)
- Greenbrook - Frederick — Frederick, Maryland, United States (enrolling)
- Greenbrook - Glen Burnie — Glen Burnie, Maryland, United States (enrolling)
- Greenbrook - Greenbelt — Greenbelt, Maryland, United States (enrolling)
- Greenbrook - Kensington — Kensington, Maryland, United States (enrolling)
- Greenbrook - Olney — Olney, Maryland, United States (enrolling)
- Greenbrook - Rockville — Rockville, Maryland, United States (enrolling)
- Greenbrook - O'Fallon — O'Fallon, Missouri, United States (enrolling)
- Greenbrook - Tesson Ferry — St Louis, Missouri, United States (enrolling)
- Greenbrook - Creve Coeur — St Louis, Missouri, United States (enrolling)
- Greenbrook - Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- Greenbrook - Greensboro — Greensboro, North Carolina, United States (enrolling)
- Greenbrook - Matthews — Matthews, North Carolina, United States (enrolling)
- Greenbrook - Raleigh — Raleigh, North Carolina, United States (enrolling)
- Greenbrook - Glen Allen — Glen Allen, Virginia, United States (enrolling)
- Greenbrook TMS NeuroHealth Centers — McLean, Virginia, United States (enrolling)
- Greenbook - Newport News — Newport News, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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